- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05631483
COlombia DAISe FEasibility Exercise (COFEE)
March 11, 2024 updated by: MIVI Neuroscience, Inc.
A Feasibility Study for the DAISe Thrombectomy Device in Colombia
This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chris Pierzchalski
- Phone Number: 2623910954
- Email: cpierzchalski@mivineuro.com
Study Contact Backup
- Name: Carlos Valverde, MD
- Phone Number: 7863199950
- Email: cvalverde@cosmosscientific.com
Study Locations
-
-
Antioquia
-
Itagüí, Antioquia, Colombia
- Recruiting
- Angiosur - Unidad Vascular Integral
-
Contact:
- Carlos Valverde, MD
- Phone Number: +573008148383
- Email: cvalverde@cosmosscientific.com
-
Principal Investigator:
- Boris Pabon, MD
-
Sub-Investigator:
- Manuel Patino, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 years or older.
- Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-2.
- Diagnosis of acute ischemic stroke with study enrollment time < 8 hours from onset of symptoms.
- Disabling stroke defined as a baseline NIHSS > 6.
- Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1.
- Signed informed consent from patient or legal representative.
Exclusion Criteria:
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
- Rapidly improving neurological deficits based on the investigator's clinical judgement.
- Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
- Severe contrast allergy or absolute contraindication to iodinated contrast.
- Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy.
- Evidence of dissection in the carotid or target artery for treatment.
- Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
- Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis).
- Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP>110 mmHg).
- Use of warfarin anticoagulation with International Normalized Ratio (INR) >3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
- Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
- Cerebral vasculitis or evidence of active systemic infection.
- Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis.
- Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
- A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DAISe
DAISe Thrombectomy Device
|
Use of the DAISe Thrombectomy Device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Successful Revascularization
Time Frame: Procedure
|
mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device
|
Procedure
|
Rate of Symptomatic Intracranial Hemorrhage
Time Frame: 24 hours post-procedure
|
24 hours post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Procedure related Complications
Time Frame: Through 90 day post-procedure
|
Through 90 day post-procedure
|
|
Occurrence of all intracranial hemorrhage
Time Frame: 24 hours post-procedure
|
24 hours post-procedure
|
|
All-cause mortality
Time Frame: Through Acute Hospital Discharge
|
Through Acute Hospital Discharge
|
|
Embolization to a New Vascular Territory
Time Frame: Procedure
|
Procedure
|
|
Successful Revascularization after first attempt with DAISe
Time Frame: Procedure
|
mTICI (modified TICI) 2b-3 after first pass with device
|
Procedure
|
Successful Revascularization after first attempt with DAISe
Time Frame: Procedure
|
mTICI (modified TICI) 2c-3 after first pass with device
|
Procedure
|
Successful Revascularization at end of procedure
Time Frame: Procedure
|
mTICI (modified TICI) 2b-3 at the end of procedure
|
Procedure
|
Successful Revascularization at end of procedure
Time Frame: Procedure
|
mTICI (modified TICI) 2c-3 at the end of procedure
|
Procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Boris Pabón, MD, Angiosur
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2022
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
October 19, 2022
First Submitted That Met QC Criteria
November 19, 2022
First Posted (Actual)
November 30, 2022
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101929
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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